Syringe Assembly and Package for Distribution of Same

ABSTRACT

A package assembly includes a panel, an array of openings defined in the panel, and a plurality of syringe wells. The panel includes an upper surface, Each of the syringe wells is individually associated with a different one of the openings. The panel and the plurality of syringe wells are integrally formed as a unitary structure. Each of the syringe wells is configured to removeably receive a syringe assembly.

BACKGROUND

1. Technical Field

The present disclosure relates to syringes and, more particularly, tomedical syringe assemblies such as disposable syringes and prefilledsyringes, which include a selectively attachable/detachable plunger rod,and packages for distribution of the same.

2. Discussion of Related Art

A conventional syringe typically includes a hollow barrel configured toslidably receive a plunger having a piston supported on a distal endthereof. The plunger is received in the hollow barrel and partiallyextends through a proximal end thereof. In use, as the plunger istranslated relative to the hollow barrel, the piston is also translatedto thereby aspirate and/or dispense fluid into/out of the hollow barrel.

Syringes have been developed for use as disposable syringes that arediscarded after a single administration and which include a selectivelyattachable/detachable plunger assembly. A single-use syringe preventsreuse of the syringe to minimize exposure of patients to HIV, hepatitisand other blood-borne pathogens.

In the case of pre-filled syringes, the syringe is provided with abarrel containing a fluid and with the plunger pre-attached to thebarrel. In the instance of relatively large pre-filled syringes, theportion of the plunger extending from the barrel may be relativelylarge. To reduce the overall length of the pre-filled barrel andplunger, pre-filled syringes have been developed wherein the plunger isselectively attachable/detachable to/from the piston. In this manner,syringes including pre-filled barrels and separate plungers may bestored and shipped at reduced costs.

SUMMARY

A need exists for syringes to be manufactured, sterilized anddistributed in a structured configuration suitable for presentation toautomated syringe-filling operations.

The present disclosure relates to a package assembly including a panel,an array of openings defined in the panel, and a plurality of syringewells. The panel includes an upper surface. Each of the syringe wells isindividually associated with a different one of the openings. The paneland the plurality of syringe wells are integrally formed as a unitarystructure. Each of the syringe wells is configured to removeably receivea syringe assembly.

The present disclosure also relates to a package assembly including apanel and a plurality of syringe assemblies. The panel is formed of aplurality of syringe flanges coupled together in a breakawayconfiguration. Each syringe assembly of the plurality of syringeassemblies is individually coupled to a different one of the syringeflanges.

The present disclosure also relates to a package assembly including aplurality of syringe packages. Each syringe package includes a connectormember and a syringe well coupled to the connector member. The syringewell is configured to removeably receive a syringe assembly. Theconnector member is configured to releaseably couple adjacent syringepackages to thereby form the package assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

Objects and features of the presently disclosed syringe assemblies andpackages for distribution of the same will become apparent to those ofordinary skill in the art when descriptions of various embodimentsthereof are read with reference to the accompanying drawings, of which:

FIG. 1 is a perspective view of a syringe assembly and a packageassembly including an array of syringe wells according to an embodimentof the present disclosure;

FIG. 2 is an enlarged, perspective view of the syringe assembly shown inFIG. 1 according to an embodiment of the present disclosure;

FIG. 3 is an enlarged, perspective view of another embodiment of asyringe assembly including a plunger assembly with parts separated inaccordance with the present disclosure;

FIG. 4 is a perspective view of the package assembly of FIG. 1 shownwith syringe assemblies (in phantom lines) disposed in the array ofsyringe wells according to an embodiment of the present disclosure;

FIG. 5 is a perspective view of the package assembly of FIG. 4 shownwith a sterile barrier film according to an embodiment of the presentdisclosure;

FIG. 6 is a perspective view of a syringe assembly as shown in FIG. 1and another embodiment of a package assembly in accordance with thepresent disclosure;

FIG. 7 is a perspective view of the package assembly of FIG. 6 shownwith sealing caps according to an embodiment of the present disclosure;

FIG. 8 is a perspective view of a syringe assembly including a flangeand a package assembly according to another embodiment of the presentdisclosure;

FIG. 9 is an enlarged, perspective view of the syringe assembly shown inFIG. 8 according to an embodiment of the present disclosure;

FIG. 10 is a perspective view of another embodiment of a packageassembly including an array of syringe packages in accordance with thepresent disclosure;

FIG. 11 is a perspective view of the package assembly of FIG. 10 shownwith syringe assemblies (in phantom lines) disposed in syringe wells ofthe array of syringe packages according to an embodiment of the presentdisclosure; and

FIG. 12 is an enlarged, perspective view of a connector member of thepackage assembly of FIG. 10 according to an embodiment of the presentdisclosure,

DETAILED DESCRIPTION

Hereinafter, embodiments of a syringe assembly and a package fordistribution of syringe assemblies of the present disclosure aredescribed with reference to the accompanying drawings. Like referencenumerals may refer to similar or identical elements throughout thedescription of the figures. As shown in the drawings and as used in thisdescription, and as is traditional when referring to relativepositioning on an object, the term “proximal” refers to that portion ofthe apparatus, or component thereof, closer to the user and the term“distal” refers to that portion of the apparatus, or component thereof,farther from the user.

This description may use the phrases “in an embodiment,” “inembodiments,” “in some embodiments,” or “in other embodiments,” whichmay each refer to one or more of the same or different embodiments inaccordance with the present disclosure. For the purposes of thisdescription, a phrase in the form “NB” means A or B. For the purposes ofthe description, a phrase in the form “A and/or B” means “(A), (B), or(A and B)”. As it is used in this description, “plastic” generallyrefers to any of a wide variety of resins or polymers with differentcharacteristics and uses.

Embodiments of the presently-disclosed syringe assembly are suitable foruse as disposable syringes and prefilled syringes. Embodiments of thepresently-disclosed package assembly allow syringes to be manufactured,sterilized and distributed in a structured configuration suitable forpresentation to automated syringe-filling operations. The teachings ofthe present disclosure may apply to a variety of syringe assemblies thatinclude a selectively attachable/detachable plunger assembly.

FIGS. 1, 4 and 5 illustrate one embodiment of the presently-disclosedsyringe assembly shown generally as 10 and package assembly showngenerally as 100. Syringe assembly 10 may be a single-use assembly,which is disposable after use on a subject. Syringe assembly 10, whichis described in more detail later in this disclosure, is suitable foruse in pre-filled applications.

Package assembly 100 includes a panel 110, an array of openings 115defined in the panel 110, and a plurality of syringe wells 140, whereineach of the syringe wells 140 is individually associated with adifferent one of the openings 115. Openings 115 may be arranged in anysuitable configuration, for example in a series of rows and/or columns,and may be uniformly spaced apart. Each of the openings 115 has asuitable diameter “D0”, and may be configured to allow robotic handlingequipment to insert and/or remove the syringe assemblies 10 through theopenings 115. Each of the plurality of syringe wells 140 includes aninterior cavity 148 of sufficient diameter to removeably receive asyringe assembly 10.

In embodiments, the panel 110 and the syringe wells 140 are integrallyformed as a unitary structure by a suitable molding process, such asinjection molding. Panel 110 and the syringe wells 140 may be formed byinjection-molding devices from suitable polymeric materials, forexample, polyolefins such as polypropylene. Syringe wells 140 and/or thepanel 110 may be transparent or semi-transparent, which may allow a userto visually inspect the syringe assemblies 10 disposed within thesyringe wells 140.

Panel 110 includes an upper surface 111, which may be flat orsubstantially flat, and a lower surface 112. In some embodiments, thepanel 110 has a generally rectangular shape, which may be formed from afirst side “S1”, a second side “S2”, a third side “S3” and a fourth side“S4”. It is also envisioned that the panel may assume otherconfigurations, e.g., circular, square, triangle, octagon, etc. Ascooperatively shown in FIGS. 1 and 4, the first side “S1” and the secondside “S2” have a suitable length “L1”, and the third side “S3” and thefourth side “S4” have a suitable length “L2”. In some embodiments, thefirst side “S1” and the second side “S2” are disposed perpendicular tothe third side “S3” and the fourth side “S4”. Panel 110 may befabricated from a suitably rigid material. In some embodiments, thepanel 110 is formed substantially or entirely from a polymeric material,e.g., plastic.

In some embodiments, one or more cut-out portions 116 are defined in thepanel 110, e.g., to facilitate gripping the package assembly 100 and/orto allow the panel 110 to be positionable in a predetermined orientationfor syringe filling operations. In one embodiment, panel 110 includestwo cut-out portions 116 disposed on opposite sides of the panel 110,e.g., the third side “S3” and the fourth side “S4”. Package assembly 100may include one or more rib elements 117, which may be disposed inproximity to the one or more cut-out portions 116 and configured toprovide structural support and rigidity to the panel 110. Rib elements117 may be coupled to the upper surface 111 of the panel 110 and/or thelower surface 112 of the panel 110. In the embodiment illustrated inFIGS. 1, 4 and 5, the package assembly 100 includes two cut-out portions116 and two rib elements 117, wherein each rib element 117 has agenerally U-like shape and is disposed in proximity to a correspondingone of the cut-out portions 116.

The plurality of syringe wells 140 are generally arranged in a patternof rows and/or columns. Alternatively, other patterns are envisioned.Openings 115 and the syringe wells 140 may be arranged as nested rowsand columns. Each of the plurality of syringe wells 140 includes an openend 147, a closed end 146, and a sleeve body 145, wherein an interiorcavity 148 is defined within the sleeve body 145 between the open end147 and the closed end 146 and disposed in communication with opening115 in the panel 110. Sleeve body 145 may have a generally cylindricalconfiguration, and the closed end 146 may have a rounded shape. In theembodiment illustrated in FIGS. 1, 4 and 5, the cavity 148 definedwithin the sleeve body 145 includes a first portion 141, e.g., a lowerportion, having a first diameter “D1”, and a second portion 142, e.g.,an upper portion (also referred to herein as a “syringe-flange holdingarea”) having a second diameter “D2”. In the embodiment shown in FIG. 1,the first diameter D1 is smaller than the second diameter D2. In someembodiments, the first diameter may be substantially identical to thesecond diameter. In yet other embodiments, the first diameter may belarger than the second diameter which may increase the stability of thesyringe assembly package during or after the syringes are loaded. It isalso understood that although the openings 115 are shown as circles,they may have any suitable cross sectional shape, such as triangle,square and the like, It is also contemplated that a particular syringeassembly having a predetermined prefilled medicament and/or apredetermined volume of medicament may be assigned to a particular crosssectional configuration of opening 115. For example, a syringe assemblyhaving first medicament at a first volume may be loaded into a platformhaving circular openings while a syringe assembly having a firstmedicament at a second volume may be loaded into a platform havingoctagonal openings. Similarly, a syringe assembly having a secondmedicament at first volume may be loaded into a platform having a squareopening.

In FIG. 2, the syringe assembly 10 is shown and includes a syringe body12, a needle cannula 16 positioned at a distal end of the syringe body12, and a needle protector or sheath 40. Syringe body 12 defines a fluidchamber or reservoir 18 and includes a distally-positioned needle hub orsupport 20, which is disposed in fluid communication with the fluidreservoir 18. In some embodiments, the syringe body 12 is made ofplastic, e.g., transparent polypropylene. Syringe body 12 may beconstructed of nearly any polymeric or glass material. Syringe body 12has an outer diameter “D3” (shown in FIG. 1). A plunger assembly (e.g.,314 shown in FIG. 3) may be provided for assembly with the syringe body12.

Fluid reservoir 18 is generally configured to contain a material to bedispensed and/or aspirated. In embodiments, the fluid reservoir 18 mayhave an internal volume of about 0.3 ml (milliliters) to about 100 ml.Needle 16 may be a stainless steel needle secured within the needlesupport 20 in a known manner (e.g., by a suitable adhesive) at a distalend of the syringe body 12.

Needle protector or sheath 40 is configured to receive the needle 16therein and includes an open end configured to be releaseably coupleablewith the distal end of the syringe body 12 and a closed end. Sheath 40may be formed of flexible plastic materials, rigid plastic materials, orother material or materials. Sheath 40 may have a hollow, substantiallycylindrical shape. Walls of the sheath 40 may be spaced apart from theneedle 16 such that the sheath 40 does not contact needle 16.

Adjacent a proximal end of the syringe body 12 is a peripheral flange22. Syringe flange 22 includes a proximal end 21 and extendsperpendicularly beyond the periphery of the syringe body 12. Syringeflange 22 may be integrally formed with the syringe body 12. Inembodiments, the syringe flange 22 has a generally circular shape, asindicated by the dashed circle in FIG. 2. In some embodiments, thesyringe flange 22 includes a first lateral edge portion 23 a and asecond lateral edge portion 23 b, wherein the second lateral edgeportion 23 b is joined to the first lateral edge portion 23 a by curvededge portions 23 c and 23 d. First lateral edge portion 23 a and thesecond lateral edge portion 23 b may be disposed in parallel spacedrelationship to one another. As shown in FIGS. 1 and 2, the syringeflange 22 has an outer diameter “D4”.

FIG. 3 shows a syringe assembly 310 in accordance with an embodiment ofthe present disclosure that includes a syringe body 312, a needlecannula 16 positioned at a distal end of the syringe body 312, a needleprotector or sheath 40, and a plunger assembly 314. Syringe body 312 issimilar to the syringe body 12 shown in FIG. 2 except for the shape ofthe syringe flange 322. Plunger assembly 314 includes a plunger rod 324and a sealing member 326. Plunger rod 324 may include a plurality ofvanes extending outwardly from a center longitudinal axis and extendingat substantially right angles to each other. In one embodiment, theplunger rod 324 is made of plastic. Sealing member 326 is configured tobe slidably received within fluid reservoir 318 of the syringe body 312and includes one or more annular ribs 330 that sealingly engage an innerwall of syringe body 312 defining reservoir 318. In one embodiment, thesealing member 326 is formed from an elastomeric material.

In FIG. 4, a plurality of the syringe assemblies 10 are shown (inphantom lines) disposed within the syringe wells 140 of the packageassembly 100. Syringe assemblies 10 are oriented generallyperpendicularly to the generally planar panel 110. Syringe assemblies 10are loaded into the package assembly 100 such that the distal end of thesyringe body 12, covered by the sheath 40, faces the closed end 146 ofthe syringe well 140 and the proximal end 21 of the syringe flange 22faces upward. In some embodiments, the syringe flange 22 is positionedin the syringe-flange holding area 142 such that the proximal end 21 ofthe syringe flange 22 is flush or substantially flush with the uppersurface 111 of the panel 110. The proximal end 21 of the syringe flange22 may alternatively be recessed from the upper surface 111. In oneembodiment, the syringe-flange holding area 142 is configured to receivesyringe flange 22 in corresponding relation. Alternatively,syringe-flange holding area 142 may be configured to receive flange 322of syringe assembly 310.

In some embodiments, fluid reservoir 18 is filled with a solution (notshown) before the syringe assembly 10 is loaded into a syringe well 140of the package assembly 100. In other embodiments, the syringe assembly10 is loaded into a syringe well 140 before the fluid reservoir 18 isfilled with a solution. In certain applications, syringe assembly 10 maycontain a flushing solution, e.g., saline or the like. Alternatively,syringe assembly 10 may contain medicinals, including antibiotics, painmedication, therapeutic drugs, heparin or the like.

FIG. 5 shows a sterile barrier film 570 disposed on the upper surface111 of the panel 110. Barrier film 570 may be adhered to the uppersurface 111 of the panel 110 by an adhesive layer (not shown), or othersuitable manner of adhesion, welding or the like. Barrier film 570 maybe applied to the upper surface 111 of the panel 110 after the syringeassemblies 10 are loaded into the syringes well 140, sterilized, and/orfilled with a solution.

FIGS. 6 and 7 illustrate another embodiment of the presently-disclosedpackage assembly shown generally as 600. Package assembly 600 includesthe panel 110 and the syringe wells 140 of FIG. 1. Package assembly 600may be formed as a unitary structure of an injection-molded polymericmaterial. Package assembly 600 is similar to the package assembly 100 ofFIGS. 1, 4 and 5 except for a plurality of sealing-cap receiving members613 coupled to the upper surface 111 of the panel 110 and a plurality ofsealing caps 653 (FIG. 7), which are configured to be releaseablycoupleable to the sealing-cap receiving members 613. Each of theplurality of sealing-cap receiving members is individually associatedwith a different opening 115 in the panel 110. Sealing caps 653 may bereleaseably connectable to the sealing-cap receiving members 613 by anysuitable manner of releasable connection, e.g., snap-fit, press-fit,screw-fit, bayonet-fit, friction fit, releasable adhesive, or otherreleasable configuration.

FIGS. 8 and 9 illustrate an embodiment of the presently-disclosedpackage assembly shown generally as 800. Package assembly 800 includes apanel 810 formed of a plurality of syringe flanges 822 coupled to oneanother in a breakaway configuration.

Package assembly 800 includes a plurality of syringe assemblies 890,which are similar to the syringe assemblies 10 of FIG. 2, except for asyringe flange 822. Syringe flanges 822 each define an opening 815therein and include an upper surface 811. In the embodiment illustratedin FIGS. 8 and 9, each of the syringe flanges 822 includes a firstlateral edge “E1”, a second lateral edge “E2”, a third lateral edge “E3”a fourth lateral edge “E4”, a fifth lateral edge “E5” and a sixthlateral edge “E6”. In embodiments, the third lateral edge “E3” and thesixth lateral edge “E6” are disposed in a parallel spaced relationshipto one another, the first lateral edge “E1” and the fourth lateral edge“E4” are disposed in a parallel spaced relationship to one another, andthe second lateral edge “E2” and the fifth lateral edge “E5” aredisposed in a parallel spaced relationship to one another. Syringeflanges 822 may be formed of a suitable plastic material, or othermaterial or materials. The number, shape and size of the syringe flanges822 may be varied from the configuration depicted in FIGS. 8 and 9.

FIGS. 10 and 11 illustrate an embodiment of the presently-disclosedpackage assembly shown generally as 1000. Package assembly 1000 includesa plurality of syringe packages 1090, wherein each of the syringepackages 1090 includes a syringe well 1040 and a connector member 1072.In the embodiment illustrated in FIGS. 10 through 12, the connectormember 1072 includes six lateral surfaces “LS”, wherein three, adjacent,lateral surfaces “LS” are provided with male-connector elements 1071 andthree, adjacent, lateral surfaces “LS” are provided withfemale-connector elements 1070, which are configured to matingly engagethe male-connector elements 1071. In the embodiment shown, each of themale-connector elements 1071 include a triangular dove-tailconfiguration and the female-connector elements 1070 includecorrespondingly shaped recesses. Alternatively, other interlockingconfigurations are envisioned. Additionally, a fewer number of connectorelements, e.g., two male connector elements and two female connectorelements, may be provided to the connector member 1072.

Although embodiments have been described in detail with reference to theaccompanying drawings for the purpose of illustration and description,it is to be understood that the inventive processes and apparatus arenot to be construed as limited thereby. It will be apparent to those ofordinary skill in the art that various modifications to the foregoingembodiments may be made without departing from the scope of thedisclosure.

1-8. (canceled)
 9. A package assembly of claim 1, comprising: a panelincluding an upper surface; a plurality of openings defined in thepanel, a plurality of syringe wells, each syringe well individuallyassociated with a different one of the openings; wherein the panel andthe plurality of syringe wells are integrally formed as unitarystructure and each of the syringe wells is configured to removeablyreceive a syringe assembly, further comprising: a plurality ofsealing-cap receiving members coupled to an upper surface of the panel,wherein each of the plurality of sealing-cap receiving members isindividually associated with a different opening in the panel.
 10. Thepackage assembly of claim 9, further comprising: a plurality of sealingcaps configured to be releaseably coupleable to the plurality ofsealing-cap receiving members. 11-12. (canceled)
 13. A package assembly,comprising: a plurality of syringe packages, each syringe packageincluding: a connector member; and a syringe well coupled to theconnector member, the syringe well configured to removeably receive asyringe assembly; wherein the connector member is configured toreleaseably couple adjacent syringe packages of the plurality of syringepackages to thereby form the package assembly.
 14. The package assemblyof claim 13, wherein the connector member includes six lateral surfaces.15. The package assembly of claim 14, wherein three of the lateralsurfaces are provided with male-connector elements.
 16. The packageassembly of claim 15, wherein three of the lateral surfaces not providedwith male-connector elements are provided with female-connectorelements.
 17. The package assembly of claim 15, wherein themale-connector elements include a triangular dove-tail configuration.18. The package assembly of claim 17, wherein the three lateral surfacesprovided with male-connector elements are disposed adjacent to oneanother, and the three lateral surfaces provided with female-connectorelements are disposed adjacent to one another.